Randomized, Double-Blind, Placebo Controlled Phase II Study of FOLFOX +/- Ziv-Aflibercept in Patients With Advanced Esophageal and Gastric Cancer
If patients agree to participate in this research study, they will be asked to undergo some
screening tests or procedures to find out if they are eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if it turns out
that patients do not take part in this research study. If patients have had some of these
tests or procedures recently, they may or may not have to be repeated. These tests and
procedures include: a medical history, physical examination, EKG, CT, Blood tests, pregnancy
test, urine test, additional blood tests for research and a collection of archival tumor
tissue. The screening tests will be reviewed by the doctor and the study team and if the
patient meets the eligibility criteria for this study, they will begin treatment. If the
patient does not meet the eligibility criteria, they will not be able to participate in this
After the screening procedures confirm that a participant is eligible to participate in the
research study, they will be "randomized" into one of two groups. A participant will receive
mFOLFOX6 with Ziv-aflibercept -or- mFOLFOX6 with Placebo (A Placebo contains no medicine)
Randomization means that a participant is put into a group by chance (like flipping a coin).
Neither the participant nor the research doctor will choose what group the participant will
be in. Randomization will be 2:1 (twice as many of the participants in this study will
receive mFOLFOX6+Ziv-aflibercept). This study is "blinded", which means neither the patient
nor the doctor will know if the patient is getting the investigational drug or the placebo
with the mFOLFOX6.
Before a participant begins mFOLFOX6 chemotherapy, they will have a central venous line
inserted for the intravenous (in a vein) chemotherapy administration. This is called a
"port" or vascular access device. Insertion of the port is a minor outpatient surgical
procedure that is performed by a surgeon or interventional radiologist depending on where it
is done. The doctor will arrange for the participant to have this procedure done before the
mFOLFOX6 is a combination of chemotherapy including oxaliplatin, leucovorin, and 5-FU. The
oxaliplatin and leucovorin are given intravenously over 2 hours. The 5-FU is also given
intravenously. The participant will get a shot of 5-FU by the infusion nurse and then will
be hooked up to a portable pump which will infuse the rest of the 5-FU slowly over the next
46-48 hours. The participant can either disconnect the pump at home, or return to the
infusion unit to have it disconnected. The participant, the caregivers and the nurse will
discuss the best option for disconnecting the pump and the patient will receive instructions
on how to do this at home, if applicable.
Ziv-aflibercept/Placebo will be given over 1 hour intravenously.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Estimate efficacy of Ziv-aflibercept+mFOLFOX6 in esophagogastric adenocarcinomas, as measured by progression-free survival (PFS).
To estimate the efficacy of Ziv-aflibercept used in combination with mFOLFOX6 in patients with previously untreated advanced esophagogastric adenocarcinoma, as measured by progression-free survival (PFS), measured from the date of initial treatment to first objective documentation of progressive disease or date of death, whichever occurs first.
Peter Enzinger, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|